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Oral Colchicine Combined With Intravitreal Infusion of Dexamethasone, LMW Heparin and 5-FU for Management of Proliferative Vitreoretinopathy (PVR)

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ClinicalTrials.gov Identifier: NCT00370760
Recruitment Status : Unknown
Verified June 2008 by Shahid Beheshti University of Medical Sciences.
Recruitment status was:  Recruiting
First Posted : September 1, 2006
Last Update Posted : June 26, 2008
Sponsor:
Information provided by:

Study Description
Brief Summary:
To evaluate the efficacy of oral colchicine combined with intraoperative infusion of dexamethasone, low molecular weight heparin and 5-FU during vitrectomy for management of established proliferative vitreoretinopathy (PVR)

Condition or disease Intervention/treatment Phase
Proliferative Vitreoretinopathy Drug: oral colchicine, dexamethasone, low molecular weight heparin, 5-FU Drug: placebo Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : September 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Thinners
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: 1 Drug: oral colchicine, dexamethasone, low molecular weight heparin, 5-FU
Placebo Comparator: 2 Drug: placebo


Outcome Measures

Primary Outcome Measures :
  1. Retinal reattachment rate

Secondary Outcome Measures :
  1. PVR recurrence,
  2. macular pucker,
  3. reoperation,
  4. ocular hypotony,
  5. visual acuity

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Cases with rhegmatogenous retinal detachment complicated by PVR grade C

Exclusion Criteria:

  • History of pars plana vitrectomy for PVR grade C
  • History of silicone oil injection
  • History of ocular trauma
  • Diabetic retinopathy
  • Glaucoma
  • Giant retinal tear
Contacts and Locations

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00370760


Contacts
Contact: Hamid Ahmadieh, MD +98 21 22585952 hahmadieh@hotmail.com

Locations
Iran, Islamic Republic of
Hamid Ahmadieh, MD Recruiting
Tehran, Iran, Islamic Republic of, 16666
Contact: Hamid Ahmadieh, MD    +98 21 22585952    hahmadieh@hotmail.com   
Sponsors and Collaborators
Shahid Beheshti University of Medical Sciences
Investigators
Principal Investigator: Hamid Ahmadieh, MD Ophthalmic Research Center of Shaheed Beheshti Medical University
More Information

ClinicalTrials.gov Identifier: NCT00370760     History of Changes
Other Study ID Numbers: 8404
First Posted: September 1, 2006    Key Record Dates
Last Update Posted: June 26, 2008
Last Verified: June 2008

Keywords provided by Shahid Beheshti University of Medical Sciences:
PVR
Oral colchicine
Dexamethasone
low molecular weight heparin
5-FU

Additional relevant MeSH terms:
Vitreoretinopathy, Proliferative
Retinal Diseases
Eye Diseases
Dexamethasone acetate
Dexamethasone
BB 1101
Calcium heparin
Heparin
Heparin, Low-Molecular-Weight
Dalteparin
Colchicine
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents
Gout Suppressants
Antirheumatic Agents